Quality Systems Engineering Intern New

Lexington Medical, Inc.; Bedford, Northern (MA, KY); Hybrid; USD 25,000 - 39,000; Full time

Job summary

Lexington Medical, Inc. in Bedford, MA seeks a Quality Systems Engineering Intern to drive three real projects, from training program development to supplier documentation updates.

You’ll work closely with Quality, Regulatory, Production, and department leaders to implement SOPs and assess training effectiveness. The role offers hands-on experience in medical-device quality systems, pFMEAs, and EU MDR documentation, preparing you for a career in quality engineering within a fast-paced

Qualifications

• Pursuing a bachelor’s degree in engineering or related field.
• Genuine interest in quality systems for medical devices.
• Strong attention to detail and comfort following procedures.
• Clear written and verbal communication across departments.
• Strong organization and ability to manage multiple projects.
• Self-motivated with guidance.
• Familiarity with ISO 13485, 21 CFR 820 / QMSR, or EU MDR is a plus.
• Prior internship or co-op in medical devices is a plus.

Responsibilities

• Write and maintain a project plan with milestones and review progress weekly.
• Meet with department heads to identify and prioritize SOPs for training.
• Create 5–10 knowledge check quizzes and roll them out in Arena for SOP retraining.
• Review pFMEAs with production leads to identify high-risk operations.
• Define methods to evaluate training effectiveness for operators.
• Draft a work instruction for the training effectiveness process.
• Coordinate with suppliers to obtain updated quality questionnaires and certificates.
• Request REACH and RoHS documentation to support EU MDR requirements.
• Escalate gaps or nonconforming findings to the Quality team.
• Present projects and results to the team at summer’s end.

Skills

Quality systems

Attention to detail

Communication

Project coordination

Self-motivated

ISO 13485 familiarity

Education

Bachelor's degree in engineering

Job description

As a Quality Systems Engineering Intern at Lexington Medical, you will run three real quality system projects at our Bedford, MA medical device company, from supplier compliance to production training. Your work willgo through our document control process and be put intousein our live quality system.

About Lexington Medical

Lexington Medical designs and manufactures AEON™ surgical stapling technology at our headquarters in Bedford, Massachusetts, just outside Boston. Our products are used in minimally invasive surgery, where precision, reliability, and quality matter every time. Because engineering, manufacturing, and quality work together under one roof, the people building and supporting our products are close to both the process and the decisions behind it.

About the Role

You will join our Quality team for the summer and own three projects that strengthen how we train our people and manage suppliers. Your main project is building out our training program. You will work with department heads to identify their highest priority Standard Operating Procedures (SOPs), write short knowledge check quizzes for each one, and roll them out in Arena so that anyone retraining to a procedure shows they understood it. On the production side, you will partner with manufacturing leads to review our pFMEAs, pinpoint the highest risk operations, and define how we evaluate training effectiveness for the operators who perform them.

Alongside those projects, you will help bring our supplier quality records up to date by working directly with suppliers to refresh questionnaires and certificates and to gather REACH and RoHS compliance documentation that supports EU MDR compliance. You will not be siloed in one area. This role puts you in regular contact with Quality, Regulatory, Production, and department leaders across the company, and it is a strong introduction to quality systems, a side of engineering many students have not seen yet.

Responsibilities

• Write and maintain a project plan with milestones for your projects, and review progress weekly with your manager.
• Meet with department heads to identify the SOPs that matter most for their teams and prioritize them for training.
• Write 5 to 10 question knowledge check quizzes for priority SOPs and help roll them out in Arena as part of SOP retraining.
• Review product pFMEAs with production leads to identify the highest risk operations.
• Define and document methods for evaluating operator training effectiveness on those operations, then help carry out and record the assessments.
• Draft a work instruction that defines the training effectiveness process, so it continues after the summer.
• Contact suppliers to obtain updated quality questionnaires and certificates, following up until documentation is complete and on file.
• Request and track REACH and RoHS compliance documentation from suppliers to support EU REACH, RoHS, and MDR requirements.
• Escalate gaps or nonconforming findings to the Quality team.
• Present your projects and results to the team at the end of the summer.

Qualifications

• Currently pursuing a bachelor’s degree in engineering (biomedical, mechanical, industrial, chemical, or a related discipline).
• Genuine interest in quality systems and how medical device companies build and maintain them.
• Strong attention to detail and comfort following written procedures.
• Clear written and verbal communication, since much of the role involves working with suppliers and colleagues across departments.
• Strong organization and follow-through, with the ability to keep several projects and requests moving at once.
• Self-motivated and comfortable taking ownership of work with guidance rather than step-by-step direction.
• A plus: basic familiarity with ISO 13485, 21 CFR 820 / QMSR, or EU MDR.
• A plus: prior internship or co-op experience, especially in medical devices.

What Success Looks Like

• By the end of week two, your project plan is set, with milestones agreed with your manager.
• By midsummer, supplier documentation outreach is well underway and your priority SOP list is set with department heads.
• By the end of the summer, SOP quizzes are live in Arena, a documented training effectiveness process is in place for high-risk production operations, and supplier documentation is current, with any remaining gaps escalated.
• An excellent intern keeps all three projects moving at the same time, follows up without needing reminders, and leaves behind work the team keeps using.

Location & Work Arrangement

This position is based at our headquarters in Bedford, Massachusetts, in the Greater Boston area, and is an on-site role. This is a full-time summer internship running from ~June to ~August.

Visit our Candidate Journey page to learn what to expect from our hiring process.